Harmonic Cold Plasma Devices and Associated Methods

ABSTRACT

A nozzle for attachment to a cold plasma device configured to maintain delivery of a stable cold plasma. The nozzle can have many different shaped apertures to support different applications requiring different shaped cold plasma plumes. Use of a disc of foam material within a nozzle can expand the size of aperture of a nozzle while maintaining delivery of a stable cold plasma. The nozzle can be an elongated cannula tube for internal delivery of a cold plasma treatment. The cannula tube can provide an aperture at its distal end or one or more apertures along its length. A shroud can partially enclose the distal aperture of the nozzle. A sterile sleeve can be used in conjunction with a nozzle to provide a sterile means of attachment and operation of the nozzle with a cold plasma device.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit under 35 U.S.C. §119(e) ofU.S. Provisional Patent Application No. 61/535,250, entitled “HarmonicCold Plasma Devices and Associated Methods”, filed on Sep. 15, 2011,which is hereby expressly incorporated by reference in its entirety.

This application is related to U.S. patent application Ser. No.13/149,744, filed May 31, 2011, U.S. patent application Ser. No.12/638,161, filed Dec. 15, 2009, U.S. patent application Ser. No.12/038,159, filed Feb. 27, 2008, and U.S. Provisional Application No.60/913,369, filed Apr. 23, 2007, each of which are herein incorporatedby reference in their entireties.

BACKGROUND

1. Field of the Art

The present invention relates to devices and methods for creating coldplasmas, and, more particularly, to such devices that are hand-held andmethods for using same.

2. Background Art

Atmospheric pressure hot plasmas are known to exist in nature. Forexample, lightning is an example of a DC arc (hot) plasma. Many dc arcplasma applications have been achieved in various manufacturingprocesses, for example, for use in forming surface coatings. Atmosphericpressure cold plasma processes are also known in the art. Most of the ator near atmospheric pressure cold plasma processes are known to utilizepositive to negative electrodes in different configurations, whichrelease free electrons in a noble gas medium.

Devices that use a positive to negative electrode configuration to forma cold plasma from noble gases (helium, argon, etc.) have frequentlyexhibited electrode degradation and overheating difficulties throughcontinuous device operation. The process conditions for enabling a densecold plasma electron population without electrode degradation and/oroverheating are difficult to achieve.

Different applications of cold plasma devices require different sizecold plasma plumes and different dimensional devices to produce thosecold plasma plumes. For example, some medical treatments require a largecold plasma plume to treat a large external wound, while othertreatments require a small cold plasma device that can be coupled to anelongated medical device that can traverse a small body passageway toreach a small internal treatment site.

Therefore, it would be beneficial to provide a device for producing acold plasma that overcomes the difficulties inherent in prior knowndevices.

BRIEF SUMMARY OF THE INVENTION

Embodiments are described that provide cold plasma for a number ofapplications including medical applications and the like.

An embodiment of a cold plasma device is described that has a housinghaving a high voltage electrical inlet port and a gas compartment, withthe gas compartment having a gas inlet port and a gas outlet port. Theembodiment also has an electrode disposed within the gas compartment,wherein the electrode is coupled to the high voltage electrical inletport. The embodiment also has a nozzle having a proximal aperture and adistal aperture, the proximal aperture being configured to be coupled tothe gas outlet port, and the nozzle being configured to maintain astable cold plasma plume exiting from the distal aperture.

An embodiment of a cold plasma method is described that includes a stepof connecting a nozzle to a cold plasma device, with an attachmentmechanism being external to a sterile sleeve, and a remainder of thenozzle enclosed in a sterile sleeve. The embodiment also includes a stepof inverting the sterile sleeve over the cold plasma device andattachment mechanism to thereby expose the distal aperture of the nozzlefor use.

An embodiment of a cold plasma method is described that includes a stepof forming a nozzle configured to couple to a cold plasma device. Theembodiment also includes steps of forming a sterile sleeve having anattachment mechanism, attaching a sterile sleeve to the nozzle via theattachment mechanism such that the distal aperture is enclosed in thesterile sleeve, and sterilizing the nozzle and sterilize sleeve.

An embodiment of a cold plasma method is described that includes a stepof grasping a nozzle through a sterile sleeve such that contact is madewith an inner portion of the sterile sleeve. The embodiment alsoincludes steps of attaching the nozzle to a cold plasma device, andinverting the sterile sleeve to enclose the cold plasma device, and aportion of a power cord associated with the cold plasma device.

An embodiment of a cold plasma method is described that includes a stepof providing a gas cartridge, with the gas cartridge including asuitable amount of gas, and the gas cartridge having a connector. Theembodiment also includes steps of providing a cold plasma hand piece,the cold plasma hand piece having a mating connector to the connector inthe gas cartridge, providing a nozzle, the nozzle configured to maintaina stable cold plasma plume exiting from the cold plasma hand piece,connecting the gas cartridge to the cold plasma hand piece using theconnector and the mating connector, determining, by the cold plasma handpiece or a pulsed high voltage power supply, a type of nozzle, adjustingone or more operating parameters of the pulsed high voltage power supplybased on the type of nozzle, and providing energy to the cold plasmahand piece from the pulsed high voltage power supply.

BRIEF DESCRIPTION OF THE DRAWINGS/FIGURES

FIGS. 1A and 1B are cutaway views of the hand-held atmospheric harmoniccold plasma device, in accordance with embodiments of the presentinvention.

FIGS. 2A and 2B illustrate an embodiment of the cold plasma devicewithout magnets, in accordance with embodiments of the presentinvention.

FIG. 3 is an exemplary circuit diagram of the power supply of a coldplasma device, in accordance with embodiments of the present invention.

FIGS. 4A and 4B illustrate a number of exemplary aperture shapes of coldplasma device nozzles, in accordance with embodiments of the presentinvention.

FIG. 5 illustrates an exemplary nozzle assembly for a cold plasmadevice, in accordance with an embodiment of the present invention.

FIG. 6 illustrates an exemplary nozzle having a plurality ofsub-apertures within the body length of the nozzle, in accordance withan embodiment of the present invention.

FIG. 7 illustrates an exemplary cannula tube for a cold plasma device,in accordance with an embodiment of the present invention.

FIG. 8 illustrates an exemplary cannula tube with one or more aperturesalong the length of the cannula tube, in accordance with an embodimentof the present invention.

FIG. 9 illustrates an exemplary shroud for use with a nozzle attached toa cold plasma device, in accordance with an embodiment of the presentinvention.

FIG. 10 illustrates an exemplary shroud for use with a nozzle havingmultiple output apertures, the nozzle attached to a cold plasma device,in accordance with an embodiment of the present invention.

FIG. 11 illustrates an exemplary sterile sleeve enclosing a sterilenozzle for use with a cold plasma device, in accordance with anembodiment of the present invention.

FIG. 12 illustrates an exemplary sterile sleeve in its invertedposition, the sterile sleeve now exposing a sterile nozzle for use witha cold plasma device, in accordance with an embodiment of the presentinvention.

FIG. 13 illustrates a method for manufacturing a nozzle for use with acold plasma device, in accordance with an embodiment of the presentinvention.

FIG. 14 illustrates a method of use of a nozzle in conjunction with acold plasma device, in accordance with an embodiment of the presentinvention.

DETAILED DESCRIPTION OF THE INVENTION

Cold temperature atmospheric pressure plasmas have attracted a greatdeal of enthusiasm and interest by virtue of their provision of plasmasat relatively low gas temperatures. The provision of a plasma at such atemperature is of interest to a variety of applications, including woundhealing, anti-bacterial processes, various other medical therapies andsterilization.

Cold Plasma Application Device

To achieve a cold plasma, a cold plasma device typically takes as inputa source of appropriate gas and a source of high voltage electricalenergy, and outputs a plasma plume. FIG. 1A illustrates such a coldplasma device. Previous work by the inventors in this research area hasbeen described in U.S. Provisional Patent Application No. 60/913,369,U.S. Non-provisional application Ser. No. 12/038,159 (that has issued asU.S. Pat. No. 7,633,231) and the subsequent continuation applications(collectively “the '369 application family”). The following paragraphsdiscuss further the subject matter from this application family further,as well as additional developments in this field.

The '369 application family describes a cold plasma device that issupplied with helium gas, connected to a high voltage energy source, andwhich results in the output of a cold plasma. The temperature of thecold plasma is approximately 65-120 degrees F. (preferably 65-99 degreesF.), and details of the electrode, induction grid and magnet structuresare described. The voltage waveforms in the device are illustrated at atypical operating point in '369 application family.

In a further embodiment to that described in the '369 application,plasma is generated using an apparatus without magnets, as illustratedin FIGS. 2A and 2B. In this magnet-free environment, the plasmagenerated by the action of the electrodes 61 is carried with the fluidflow downstream towards the nozzle 68. FIG. 2A illustrates a magnet-freeembodiment in which no induction grid is used. FIG. 2B illustrates amagnet-free embodiment in which induction grid 66 is used. FIG. 1Billustrates the same embodiment as illustrated FIG. 2B, but from adifferent view. Although these embodiments illustrate the cold plasma isgenerated from electrode 12, other embodiments do not power the coldplasma device using electrode 12, but instead power the cold plasmadevice using induction grid 66.

In both a magnet and a magnet-free embodiment, the inductance grid 66 isoptional. When inductance grid 66 is present, it provides ionizationenergy to the gas as the gas passes by. Thus, although the inductancegrid 66 is optional, its presence enriches the resulting plasma.

As noted above, the inductance grid 66 is optional. When absent, theplasma will nevertheless transit the cold plasma device and exit at thenozzle 68, although in this case, there will be no additional ionizationenergy supplied to the gas as it transits the latter stage of the coldplasma device.

As noted with respect to other embodiments, magnetic fields can be usedin conjunction with the production of cold plasmas. Where present,magnetic fields act, at least at some level, to constrain the plasma andto guide it through the device. In general, electrically chargedparticles tend to move along magnetic field lines in spiraltrajectories. As noted elsewhere, other embodiments can comprise magnetsconfigured and arranged to produce various magnetic field configurationsto suit various design considerations. For example, in one embodiment asdescribed in the previously filed '369 application family, a pair ofmagnets may be configured to give rise to magnetic fields with opposingdirections that act to confine the plasma near the inductance grid.

Cold Plasma Unipolar High Power Voltage Power Supply

The '369 application family also illustrates an embodiment of theunipolar high voltage power supply architecture and components usedtherein. The circuit architecture is reproduced here as FIG. 3, and thisuniversal power unit provides electrical power for a variety ofembodiments described further below. The architecture of this universalpower unit includes a low voltage timer, followed by a preamplifier thatfeeds a lower step-up voltage transformer. The lower step-up voltagetransformer in turn feeds a high frequency resonant inductor-capacitor(LC) circuit that is input to an upper step-up voltage transformer. Theoutput of the upper step-up voltage transformer provides the output fromthe unipolar high voltage power supply.

FIG. 3 also illustrates an exemplary implementation of the unipolar highvoltage power supply 310 architecture. In this implementation, a timerintegrated circuit such as a 555 timer 320 provides a low voltage pulsedsource with a frequency that is tunable over a frequency range centeredat approximately 1 kHz. The output of the 555 timer 320 is fed into apreamplifier that is formed from a common emitter bipolar transistor 330whose load is the primary winding of the lower step-up voltagetransformer 340. The collector voltage of the transistor forms theoutput voltage that is input into the lower step-up voltage transformer.The lower step-up transformer provides a magnification of the voltage tothe secondary windings. In turn, the output voltage of the lower step-upvoltage transformer is forwarded to a series combination of a highvoltage rectifier diode 350, a quenching gap 360 and finally to a seriesLC resonant circuit 370. As the voltage waveform rises, the rectifierdiode conducts, but the quench gap voltage will not have exceeded itsbreakdown voltage. Accordingly, the quench gap is an open circuit, andtherefore the capacitor in the series LC resonant circuit will chargeup. Eventually, as the input voltage waveform increases, the voltageacross the quench gap exceeds its breakdown voltage, and it arcs overand becomes a short circuit. At this time, the capacitor stops chargingand begins to discharge. The energy stored in the capacitor isdischarged via the tank circuit formed by the series LC connection.

Continuing to refer to FIG. 3, the inductor also forms the primarywinding of the upper step-up voltage transformer 340. Thus, the voltageacross the inductor of the LC circuit will resonate at the resonantfrequency of the LC circuit 370, and in turn will be further stepped-upat the secondary winding of the upper step-up voltage transformer. Theresonant frequency of the LC circuit 370 can be set to in the highkHz-low MHz range. The voltage at the secondary winding of the upperstep-up transformer is connected to the output of the power supply unitfor delivery to the cold plasma device. The typical output voltage is inthe 10-150 kV voltage range. Thus, voltage pulses having a frequency inthe high kHz-low MHz range can be generated with an adjustablerepetition frequency in the 1 kHz range. The output waveform is shapedsimilar to the acoustic waveform generated by an impulse such as when abell is struck with a hammer. Here, the impulse is provided when thespark gap or a silicon controlled rectifier (SCR) fires and produces thevoltage pulse which causes the resonant circuits in the primary andsecondary sides of the transformer to resonate at their specificresonant frequencies. The resonant frequencies of the primary and thesecondary windings are different. As a result, the two signals mix andproduce the unique ‘harmonic’ waveform seen in the transformer output.The net result of the unipolar high voltage power supply is theproduction of a high voltage waveform with a novel “electricalsignature,” which when combined with a noble gas or other suitable gas,produces a unique harmonic cold plasma that provides advantageousresults in wound healing, bacterial removal and other applications.

The quenching gap 360 is a component of the unipolar high voltage powersupply 310. It modulates the push/pull of electrical energy between thecapacitance banks, with the resulting generation of electrical energythat is rich in harmonic content. The quenching gap can be accomplishedin a number of different ways, including a sealed spark gap and anunsealed spark gap. The sealed spark gap is not adjustable, whileunsealed spark gaps can be adjustable. A sealed spark gap can berealized using, for example, a DECI-ARC 3000 V gas tube from ReynoldsIndustries, Inc. Adjustable spark gaps provide the opportunity to adjustthe output of the unipolar high voltage power supply and the intensityof the cold plasma device to which it is connected. In a furtherembodiment of the present invention that incorporates a sealed (andtherefore non-adjustable) spark gap, thereby ensuring a stable plasmaintensity.

In an exemplary embodiment of the unipolar high voltage power supply, a555 timer 320 is used to provide a pulse repetition frequency ofapproximately 150-600 Hz. As discussed above, the unipolar high voltagepower supply produces a series of spark gap discharge pulses based onthe pulse repetition frequency. The spark gap discharge pulses have avery narrow pulse width due to the extremely rapid discharge ofcapacitive stored energy across the spark gap. Initial assessments ofthe pulse width of the spark gap discharge pulses indicate that thepulse width is approximately 1 nsec. The spark gap discharge pulse traincan be described or modeled as a filtered pulse train. In particular, asimple resistor-inductor-capacitor (RLC) filter can be used to model thecapacitor, high voltage coil and series resistance of the unipolar highvoltage power supply. In one embodiment of the invention, the spark gapdischarge pulse train can be modeled as a simple modeled RLC frequencyresponse centered in the range of around 100 MHz. Based on the pulserepetition frequency of 192 Hz, straightforward signal analysisindicates that there would be approximately 2,000,000 individualharmonic components between DC and 400 MHz.

In another embodiment of the unipolar high voltage power supplydescribed above, a 556 timer or any timer circuit can be used in placeof the 555 timer 320. In comparison with the 555 timer, the 556 timerprovides a wider frequency tuning range that results in greaterstability and improved cadence of the unipolar high voltage power supplywhen used in conjunction with the cold plasma device.

Cold Plasma Plumes

The unique harmonic cold plasma resulting from the novel “electronicsignature” of the power supply applied with an appropriate noble gascombination can be used with a variety of shaped cold plasma plumes orjets. In fact, various medical treatments can require differing shapedplasma plume shapes. For example, medical treatments involvingdermatology applications, skin cancer, dental caries, very small woundsand the like are desirous of a relatively small confined cold plasmaplume shape. In fact, for the mentioned applications, the preferredplasma plume shape is one having a very small diameter coverage area. Insuch applications, a circular, pinpoint plasma jet is a preferred plumeshape. Similarly, other medical treatments can require a narrow andbroad plasma jet. For example, medical treatments involving surgicalsite applications, diabetic ulcers, large wounds and the like aredesirous of a relatively narrow but long cold plasma plume shape. Insuch applications, a slit-shaped plasma jet is a preferred plume shape.

Similarly, other medical treatments can require a wide and long plasmajet. For example, medical treatments involving certain other surgicalsite applications, and certain shapes of large wounds and the like aredesirous of a relatively wide and long cold plasma plume shape. In suchapplications, a spatula-shaped plasma jet is a preferred plume shape.

Not all medical treatment protocols are associated with treatment sitesexternal to the body of a human or animal. In many cases, the treatmentsite is internal to a body and a cold plasma treatment protocol wouldtherefore require delivery of cold plasma to that internal treatmentsite. Access to such a site can use various elongated devices, such aslaparoscopic, arthroscopic and endoscopic devices. Cold plasma isgenerated by a device such as the cold plasma application devicedescribed above, and introduced into the proximal end of one of theseelongated devices, with delivery of cold plasma at the distal end.Accordingly, the gas (helium or other biocompatible gas/gas mixture) isdelivered to the desired treatment site, together with the electricalenergy to ignite the desired reactive species, as well as any energydelivery required for RF or electroporation protocols.

Different configurations of a nozzle connected to the cold plasma deviceresult in different plasma flow pattern shapes and these plasma flowpattern shapes can be optimized for various applications. Thus, forexample, burns covering a wide area are optimally treated by a nozzlethat supports a cold plasma with a wide cross-sectional area Conversely,a small but deep wound or an internal injury is optimally treated by theuse of a nozzle connected to the cold plasma device to support a plasmaflow pattern shaped in a small circular cross-section. Other woundshapes can be optimally treated with a variety of other nozzles tosupport the required shapes such as a slit shape.

While such different plasma flow patterns require a different nozzleshape, nozzle shapes cannot be arbitrarily shaped without adverse impacton the cold plasma. In particular, the temperature and stability of thecold plasma can be adversely affected by modest changes in the nozzleconfiguration. In fact, the temperature and stability of the cold plasmaare the function of a complex relationship between such characteristicsas gas flow rate, electrode configuration, electrical power waveform,nozzle configuration and gap between target surface and nozzle.Therefore, a method to recognize the nozzle attached and adjust theseparameters (e.g. voltage, frequency, gas flow) is highly desired, and isaddressed below.

For medical devices that come into proximate or direct contact withpatients, the devices must be sterilized between uses or containdisposable components designed to reduce or eliminate the transfer ofinfection between patients. While sterilization may appear to be moreefficient, sterilization takes specialized equipment, specially trainedstaff, and additional time and resources. Even with these people andprocesses, the reprocessing of medical equipment can still be a sourceof infection. Furthermore, certain medical electronics or other complexhardware cannot tolerate the extreme temperatures, pressures, orchemical stresses of sanitization. For these reasons, disposablecomponents are increasingly common in modern healthcare delivery. Thesedisposables are well known in the medical industry and range in form andcomplexity from a simple disposable tube on the suction device at adental office to a fully customized, patient-specific, cutting guideused by an orthopedic surgeon when performing total knee replacementsurgery.

When treating open wounds with an instrument such as cold plasma, it isimportant to ensure that no new pathogens are introduced to the woundand that pathogens are not spread from patient to patient. Therefore, itis desirable to have a sterile, prepackaged, and easily exchangeabledelivery tip that can be disposed of and replaced between each use.Further, the different size, shape, and complexity of different woundsmay warrant a different size or shape to the plasma plume for apatient-specific approach to plasma wound therapy. The followingembodiments seek to meet these needs with disposable plasma nozzlescapable of generating and supporting unique and varied plasma plumeshapes.

Cold Plasma Nozzles

FIG. 4 illustrates different nozzles 410, 420 that can be affixed to theoutlet port of the cold plasma device. These nozzles represent examplesof different orifice shapes and sizes 412, 422, and are not intended tobe limiting to the scope of the invention. The illustrated nozzles 410,420 include circular and slit shaped apertures. Other shapes areincluded in the scope of embodiments of the present invention, e.g.,triangular shaped apertures. By way of example, and not as a limit tothe scope of the invention, the circular orifice can be 3, 5, 8, and 42mm in diameter. The 42 mm diameter orifice, being a larger orifice size,requires additional elements to support such a large plume, as discussedfurther below. Nozzles having a circular aperture produce essentially aconico-cylindrical plasma plume.

As noted above, other aperture shapes fall within the scope of thepresent invention. In particular, shapes configured to support plumecoverage areas such as square, oval, triangle, and the like fall withinthe scope of the present invention. To the extent that certain treatmentareas having a non-standard shape demand a cold plasma plume having acomplementary shape, an adaptable nozzle also falls within the scope ofthe present invention. An adaptable nozzle uses either a mechanicaladjustment or is formed from a malleable material having sufficientlimited range of dimensional adjustments such that the orifice oraperture shape can be modified. The limited range of dimensionaladjustment is designed to maintain a back pressure that remains withinthe range sufficient to support and maintain the cold plasma plume.

As discussed above, nozzles are attached to the outlet of the coldplasma device to provide a plasma plume comparable to that of the '369patent, but with differing coverage areas and/or shapes. Such nozzlescan be permanently affixed to the cold plasma device. In an alternativeset of embodiments, such nozzles can also be detachably affixed to thecold plasma device. Means of affixing the detachable plasma nozzlesinclude threaded screw assembly, squeeze fit, clamps, spring loadedlocking collar and other attachment means that one of ordinary skill inthe art would have familiarity. Detachable nozzles can be reusablenozzles, in that these nozzles can be used on more than one occasion. Ina set of further embodiments, the detachable nozzles can be disposablenozzles, in that the nozzles are used once and then discarded. Withremovable/disposable plasma nozzles, it can be desirable to have adust/debris cover over the outflow port when the cold plasma device isnot in use.

FIG. 5 illustrates an exemplary nozzle assembly for a cold plasmadevice, in accordance with an embodiment of the present invention. Theexemplary nozzle assembly 500 includes distal orifice 510 in an acrylicsection 520, a polypropylene distal cap 530, and silicon spacer 540.Silicon spacer 540 makes contact with cold plasma device. The particularparts shown in the assembly are merely exemplary, as are the choice ofmaterials, and other choices for coupling a nozzle to a cold plasmadevice fall within the scope of embodiments of the present invention.

In a further embodiment of the present invention, a nozzle can includemore than one aperture. For example, embodiments of the presentinvention can include a nozzle with a plurality of small apertures init, similar to a salt shaker, in order to achieve multiple smallerparallel plasma streams (not pictured).

As noted above, nozzle apertures cannot be of arbitrary dimensions yetstill sustain a cold plasma plume. For example, a nozzle aperture cannotbe arbitrarily increased without loss of a stable cold plasma plume. Tosupport a large nozzle aperture (e.g. a large circular or oval orifice,a large slit aperture) and its resulting large coverage area, anadditional material and construction step are required to effectivelydistribute the cold plasma over the larger area while maintaining asmooth and well-formed plasma plume.

In an embodiment of the present invention, as illustrated in FIG. 6, aporous material can be added in the form of a disk 630 for a portion ofthe body length between proximal aperture 620 and distal aperture 640 ofthe nozzle 610. The porous material extends across the completecross-section of the nozzle 610, and thereby provides a plurality ofsmall sub-apertures through which the cold plasma travels. The thicknessof the porous material, as well as its porous nature, provide sufficientbackpressure to sustain the cold plasma plume. The use of a porousmaterial forces the cold plasma to travel through the pore structure ofthe foam while providing adequate backpressure into the plasmageneration chamber in the presence of such a large outflow from thelarge orifice of the nozzle. Some backpressure is necessary to ensuresufficient contact time between the feed gas and the RF structure forionization to occur. The porous material can be any suitable materialconsistent with the above objectives. In an exemplary embodiment, theporous material can be an open cell polyurethane foam. Consistent withthe above objectives, the polyurethane foam provides a very large,almost infinite, plurality of sub-apertures. The use of porous materialhas led to cold plasma plumes that are orders of magnitude larger thanpreviously seen. In an exemplary embodiment, a cold plasma plume of 42mm diameter can be created. In an embodiment, the porous material (e.g.,foam disk) can be located anywhere along the cold plasma path from thegun through to the disposable tip. The porous material (e.g., foam disk)would be affixed to maintain its position at its desired location sothat it is not amenable to being dislodged in response to the coldplasma flow. In an exemplary embodiment, the foam disk can be located(i.e., sandwiched) between the disposable tip and the body of the gun.Although disk 630 is shown as a cylindrical shape, the shape will beconsistent with the shape of the apertures 620, 630. Thus, for example,in the case of slit-shaped apertures, disk 630 can take on a shapehaving a rectangular cross-section. Alternatively, a single genericshape (e.g., cylindrical disk shape) can be used with a variety ofdifferent aperture cross-sections, with only the portion presented tothe aperture cross-section being active. For example, a cylindrical diskshape can be used with a slit aperture, with only the slit portion ofthe cylindrical disk being actively exposed to the cold plasma.

In a further embodiment, the inclusion of this porous material (e.g.,polyurethane foam) provides the potential for delivering additionalchemicals or drugs along with the cold plasma plume. For example, thefoam could UMe presoaked in any number of solutions such as water,saline solution, hydrogen peroxide, or powders (e.g., powderedmedications such as bleomycin, collagenase, and the like). The first twosolutions could be used to humidify the plasma, which has been shown toenhance the antimicrobial action of certain cold plasmas. The thirdsolution can enhance the oxidative potential of the cold plasma toenhance antimicrobial action or otherwise control the chemistry of thecold plasma. It may also be desirable to include antibiotic solutions orother medication, such as haemostatic agents, anesthetics, for theenhanced control of infection, bleeding, and pain from the target wound.

Cold Plasma Cannula Tubes

As noted above, not all medical treatments can be performed external tothe body of a human or animal. In many cases, the treatment site isinternal to a body and access to such a site requires the provision oftools that are placed at the end of various elongated devices, such aslaparoscopic, arthroscopic and endoscopic devices. In another embodimentof the present invention, the nozzle can be a cannula tube attached tothe outlet port of the cold plasma device. FIG. 7 illustrates anexemplary cannula tube 710. In an exemplary embodiment, cannula tube 710has a single aperture 720 at the proximal end that is attached to theoutlet port of the cold plasma device. Cannula tube 710 has a lengthsufficient to reach a desired treatment area. Typically, the treatmentarea is internal to a human being or animal, where the treatment area isaccessible via an opening such as mouth, nose, arterial or venal entrypoint, or transdermally through a port. Thus, a cannula tube can be usedfor internal treatment within any bodily lumen, cavum, vestibule orbuccal cavity. Similar to the other nozzles, the cannula tube can beeither removable or permanently affixed to the cold plasma device. Alsoin a similar manner to the other nozzles, the cannula tube can be eitherre-usable or disposable cannula tubes. In an embodiment of the presentinvention, the cannula tube has a single aperture 730 at the distal endinserted into the treatment area. Cannula tube 710 can be used forinternal treatment within any bodily lumen, cavum, vestibule, or buccalcavity.

FIG. 8 illustrates a further embodiment of the present invention, acannula tube 810 has a plurality of apertures 840 a, b, c at the distalend of the cannula tube. In various embodiments, the apertures can be atthe end or placed at a variety of locations along a portion of thelength of the cannula tube adjacent to the end of the cannula tube. Inone of these embodiments, the distal end 830 of the cannula tube can besealed, with one or more apertures 840 a, b, c located along the bodylength. Cannula tube 810 can be used for internal treatment along thelength of any bodily lumen, cavum, vestibule, or buccal cavity.

Cold Plasma Shrouds

FIG. 9 illustrates a further embodiment of the present invention, ashroud 940 can be placed so as to surround the area occupied by the coldplasma plume. The shroud functions to keep reactive species in closerproximity to the wound bed or target substrate for longer durations oftime when reactive species are desired and proper feed gas is used fortheir production. Additionally, it maintains high energy ions around thetarget area rather than allowing the energy to escape quickly into theambient environment. Thus, the shroud separates the external atmospherefrom the cold plasma. In one exemplary embodiment, shroud 940 can becone-shaped, although other shapes fall within the scope of embodimentsof the present invention. In another embodiment of the presentinvention, the shroud could also have one or more outlet apertures 1030b, c, in the form of narrow elliptical or circular ports, as illustratedin FIG. 10. The outlet apertures enable gas flow to be maintained whenthe shroud is pressed against skin or another substrate by providing anexit path for the cold plasma. In other words, the outlet aperturesallow fluid communication between the external atmosphere and the coldplasma inside the shroud. The outlet apertures can be located anywhereon the shroud. In one embodiment, the outlet apertures can be locatedproximal to the gun to ensure that the energy-rich plasma is maintainedat the treatment area, while the quenched cold plasma is released to theexternal atmosphere.

In addition, the shroud also serves to provide the medical professionalwith a minimum distance guide, i.e., the nozzle cannot approach thetreatment site any closer than that permitted by the shroud. In anembodiment, the length of the shroud can be in the range 10 to 35 mmalthough shroud lengths as small as 2 mm are within scope of embodimentsof the invention. The shroud diameter can also provide the medicalprofessional with an indication of the effective zone of treatment. Forexample, in an exemplary cold plasma treatment protocol, an 8 mmdiameter plasma can be associated with a 55 mm diameter treatment zone.Therefore, a shroud diameter of 55 mm coupled with an 8 mm aperturewould indicate to the medical professional that the cold plasmaapplication device would be moved by one-shroud-diameter to reach thenext treatment zone. Thus, the choice of shroud dimensions can dependupon the nozzle size, as well as the type of treatment protocol.

As noted above, the shroud may also function to keep the plasma streamand treatment area separate from the surrounding ambientair/environment. This could work to control plasma chemistry, forexample when pure helium is used as a feed gas, reactive O₂ and N₂species would be minimized as they are normally introduced when thehelium plasma stream causes turbulent mixing with ambient air containingO₂ and N₂ as well as H₂O.

Cold Plasma Sterile Sleeves

In a further embodiment of the present invention, nozzles are formed aspart of a sterile assembly. A sterile nozzle assembly 1100 provides forthe provision of a sterile nozzle that can be coupled to a cold plasmadevice 1210. The cold plasma device is not a sterile device, and thenon-sterile area is separated from the sterile nozzle by a protectiveelement such as a sleeve 1140.

FIG. 11 illustrates a threaded nozzle end 1150 of nozzle 1110 that isincorporated with the sterile sleeve into a single unit for the purposesof handling an insertion. Disposable nozzle 1110 could be RF welded,glued, epoxied, or otherwise permanently attached to the sterile sleeveby any means known to one familiar in the art. In an alternativeembodiment, a rubber “O” ring can be used as part of the sterile sleeve,with the rubber “O” ring placed over the threaded portion of thedisposable tip. The “O” ring is not permanently attached, but wouldfunction as a single unit.

FIG. 12 illustrates the incorporated disposable nozzle 1110 and sterilesleeve 1140 after being pulled over the cold plasma device 1210. Notethat the sleeve covers the cold plasma device, the power cord 1220associated with the cold plasma device, together with anything else thatis required to be kept apart from the sterilized aperture of thedisposable nozzle, e.g., the hand and distal arm of the medicalprofessional using the cold plasma device and disposable nozzle.

In further embodiments of the cold plasma application device and/oruniversal power supply, a smart electronics feature can be added. Withthis feature added to either the cold plasma application device and/oruniversal power supply, the power supply can recognize the type of coldplasma hand piece that is connected to the power supply, and adjust thepower supply output accordingly. For example, with a different handpiece, the output voltage, output resonant frequency or timer frequencycan be adjusted to support the particular hand piece being used. In afurther embodiment, the smart electronics can recognize not only theparticular hand piece being connected to the power supply, but also oneor more of the particular plasma nozzles being connected at the gasoutlet of the hand piece and the composition of gas and the duration oftreatment based on the connection at the gas inlet. Based on being ableto sense the plasma-nozzle-hand-piece combination, predeterminedsettings can be automatically made by the power supply in response tothese sensed configurations. The sensing process can be accomplished byany of the numerous methods by which such configuration data can beobtained. For example, the coding of the hand-piece and/or plasma nozzlecan be performed via an ID chip (e.g., a RFID chip), which can be readremotely by the appropriate RFID interrogator installed in the powersupply or the hand-piece. Other alternative means of information storageinclude electrically erasable programmable read only memory (EEPROM).Other alternatives for the sensing include the use of simplemechanical-electrical connections such as pin connectors or the use ofprinted metal stripes (similar to a barcode) on the surface of theplasma nozzle or cartridge that physically makes the desired connection.The configuration data can include the hand-piece-tip configuration, orcould also contain information such as safety and other information(such as maximums and minimums) that are set by various regulatory andother authorities. For example, the data memory can indicate the maximumtime to which a particular treatment area can be exposed. Where morecomplex relationships apply to various relevant operating parameters,such information can also be stored in the data memory. In addition toremote sensing of the data memory, wired and/or wireless connectivitycan be provided to make the relevant information available to the powersupply. In response to the received data, the power supply respondsautomatically by making the appropriate settings, such as pulsefrequency, resonance frequency, output voltage, gas flow rates, andtreatment time.

Cold Plasma Methods

FIG. 13 provides a flowchart of an exemplary method 1300 to manufacturea sterile nozzle for use with a cold plasma device, according to anembodiment of the present invention.

The process begins at step 1310. In step 1310, a nozzle is formed thatis configured to couple to a cold plasma device. In an embodiment, anozzle 1110 is configured to couple to cold plasma device 1210.

In step 1320, a sterile sleeve is attached to a nozzle such that thedistal end of the nozzle is enclosed in the sleeve. In an exemplaryembodiment, a sterile sleeve 1140 is attached to a nozzle 1110 such thatthe distal end of the nozzle is enclosed in the sleeve.

In step 1330, the nozzle and sterile sleeve are sterilized. In anembodiment, nozzle 1110 and sterile sleeve 1140 are sterilized.

In step 1340, package nozzle, sterile sleeve and optionally othercomponents, e.g., gas cartridge. In an embodiment, nozzle 1110, sterilesleeve 1140 and optionally other components, e.g., gas cartridge arepackaged together.

At step 1340, method 1300 ends.

FIG. 14 provides a flowchart of an exemplary method 1400 to use adisposable nozzle and its sterilized sleeve, according to an embodimentof the present invention.

The process begins at step 1410. In step 1410, the disposable nozzle isgrasped via the sterile sleeve so that contact with the disposablenozzle is made through the inner portion of the sterile sleeve. In anembodiment, the disposable nozzle 1110 is grasped via the sterile sleeve1140 so that contact with the disposable nozzle 1110 is made through theinner portion of the sterile sleeve 1140.

In step 1420, the disposable nozzle is attached to the cold plasmadevice. In an exemplary embodiment, the disposable nozzle 1110 isattached to the cold plasma device 1210.

In step 1430, the sterile sleeve is inverted to enclose the cold plasmadevice, a portion of a power cord associated with the cold plasmadevice, and anything else that requires shielding from the treatmentarea. In an embodiment, the sterile sleeve 1140 is inverted to enclosethe cold plasma device 1210, and a portion of a power cord 1220associated with the cold plasma device 1210. Thus, disposable nozzle1110 is not directly touched by the hand of a medical professional.Instead, what begins as the inner portion of the sterile sleeve 1140becomes the outer portion of the sterile sleeve 1140 when the disposablenozzle is in operation.

At step 1440, method 1400 ends.

It is to be appreciated that the Detailed Description section, and notthe Summary and Abstract sections, is intended to be used to interpretthe claims. The Summary and Abstract sections may set forth one or morebut not all exemplary embodiments of the present invention ascontemplated by the inventor(s), and thus, are not intended to limit thepresent invention and the appended claims in any way.

The present invention has been described above with the aid offunctional building blocks illustrating the implementation of specifiedfunctions and relationships thereof. The boundaries of these functionalbuilding blocks have been arbitrarily defined herein for the convenienceof the description. Alternate boundaries can be defined so long as thespecified functions and relationships thereof are appropriatelyperformed.

The foregoing description of the specific embodiments will so fullyreveal the general nature of the invention that others can, by applyingknowledge within the skill of the art, readily modify and/or adapt forvarious applications such specific embodiments, without undueexperimentation, without departing from the general concept of thepresent invention. Therefore, such adaptations and modifications areintended to be within the meaning and range of equivalents of thedisclosed embodiments, based on the teaching and guidance presentedherein. It is to be understood that the phraseology or terminologyherein is for the purpose of description and not of limitation, suchthat the terminology or phraseology of the present specification is tobe interpreted by the skilled artisan in light of the teachings andguidance.

The breadth and scope of the present invention should not be limited byany of the above-described exemplary embodiments, but should be definedonly in accordance with the following claims and their equivalents.

What is claimed is:
 1. A cold plasma device, comprising: a housinghaving a high voltage electrical inlet port and a gas compartment, thegas compartment having a gas inlet port and a gas outlet port; anelectrode disposed within the gas compartment, wherein the electrode iscoupled to the high voltage electrical inlet port; and a nozzle having aproximal aperture and a distal aperture, the proximal apertureconfigured to be coupled to the gas outlet port, the nozzle configuredto maintain a stable cold plasma plume exiting from the distal aperture.2. The cold plasma device of claim 1, wherein shapes of the distalaperture and the proximal aperture comprise one of circles, slits andtriangles.
 3. The cold plasma device of claim 1, wherein the nozzlecomprise a plurality of distal apertures.
 4. The cold plasma device ofclaim 1, wherein the nozzle is disposable.
 5. The cold plasma device ofclaim 1, wherein the nozzle is reusable.
 6. The cold plasma device ofclaim 1, wherein the nozzle farther comprises: a disk positioned in thenozzle between the proximal aperture and the distal aperture, the diskcomprising a material having a plurality of sub-apertures embeddedtherein such that a stable cold plasma plume exits from the distalaperture.
 7. The cold plasma device of claim 6, wherein the materialcomprises a foam-like material.
 8. The cold plasma device of claim 6,wherein the material further comprises at least one of water, salinesolution, hydrogen peroxide, antibiotic solutions, anesthetics, andhaemostatic agents.
 9. The cold plasma device of claim 1, wherein thenozzle is a cannula tube.
 10. The cold plasma device of claim 9, whereina distal end of the cannula tube is terminated and the distal apertureis located along an external surface of the cannula tube proximate tothe distal end.
 11. The cold plasma device of claim 1, furthercomprising: a sleeve affixed to a proximate end of the nozzle, thesleeve configured to enclose the nozzle in a sterile environmentseparate from an environment surrounding the housing.
 12. The coldplasma device of claim 11, wherein the sleeve is affixed using at leastone of RF welding, gluing, and epoxying.
 13. The cold plasma device ofclaim 1, further comprising: a shroud attached or formed to a proximateend of the nozzle and configured to partially envelop the volumeadjacent to the distal aperture of the nozzle to thereby reduce theinteraction of the plume with the surrounding environment.
 14. The coldplasma device of claim 13, wherein the shroud is cone-shaped.
 15. Thecold plasma device of claim 13, wherein the shroud contains: two or moreapertures.
 16. The cold plasma device of claim 1, wherein the nozzleincludes a smart nozzle recognition system comprising at least one of akeyed physical feature on the nozzle, an RFID tag on the nozzle, anelectronic microchip on the nozzle, a bar code on the nozzle, a magnetictag on the nozzle, and an optically readable tag on the nozzle.
 17. Amethod, comprising: connecting a nozzle to a cold plasma device, anattachment mechanism being external to a sterile sleeve, a remainder ofthe nozzle enclosed in a sterile sleeve; inverting the sterile sleeveover the cold plasma device and attachment mechanism to thereby exposethe distal aperture of the nozzle for use.
 18. The method of claim 17,wherein: the connecting a nozzle to a cold plasma device includesgrasping the nozzle by one or more digits such that contact by thedigits is made in an inner portion of the sterile sleeve; and invertingthe sterile sleeve substantially encloses the cold plasma device, aportion of a power cord associated with the cold plasma device.
 19. Amethod, comprising: forming a nozzle configured to couple to a coldplasma device; forming a sterile sleeve having an attachment mechanism;attaching a sterile sleeve to the nozzle via the attachment mechanismsuch that the distal aperture is enclosed in the sterile sleeve; andsterilizing the nozzle and sterilize sleeve.
 20. The method of claim 19,wherein the sterilizing includes using at least one of an autoclaveprocess, a chemical sterilization process and a gamma radiation process.21. A method, comprising: grasping a nozzle through a sterile sleevesuch that contact is made with an inner portion of the sterile sleeve;attaching the nozzle to a cold plasma device; and inverting the sterilesleeve to enclose the cold plasma device, and a portion of a power cordassociated with the cold plasma device.
 22. A method comprising:providing a gas cartridge, the gas cartridge including a suitable amountof gas, and the gas cartridge having a connector; providing a coldplasma hand piece, the cold plasma hand piece having a mating connectorto the connector in the gas cartridge; providing a nozzle, the nozzleconfigured to maintain a stable cold plasma plume exiting from the coldplasma hand piece; connecting the gas cartridge to the cold plasma handpiece using the connector and the mating connector; determining, by thecold plasma hand piece or a pulsed high voltage power supply, a type ofnozzle; adjusting one or more operating parameters of the pulsed highvoltage power supply based on the type of nozzle; and providing energyto the cold plasma hand piece from the pulsed high voltage power supply.